According to the FDA, off-label use of drug-eluting stents carries an increased risk of thrombosis, myocardial infarction and death. An FDA advisory panel recommended changing the labels of such stents. The two approved devices are Cypher (sirolimus-eluting) and Taxus (paclitaxel-eluting). Approximately 60% of the three million drug-eluting stents implanted in Americans, are off-label. In addition recommending label changes, the FDA panel also agreed that “future pre-market clinical trials of drug-eluting stents ‘should be longer and bigger and should specifically address the issue of stent thrombosis.'”
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